The present formulation relates to the field of pharmaceutical treatments for pain and in particular to severe headache such is produced by a migraine episode. The term “migraine” is used herein to mean both common migraine headache and classic migraine headache, and also any human severe headache condition although some such conditions may be referred to by other terminology in the field of medicine or by the general public.
Migraine is a painful, sometimes debilitating disorder, which is frequently associated with various neurological symptoms. Its prevalence in the population is higher than that of any other neurological disorder, thus the burden of this disease on society is considerable. Although the introduction of triptans nearly two decades ago revolutionized the treatment of the disease there is still a strong need for a more effective pharmacology. Formerly, migraine therapy primarily aimed at treating the pathological alterations of meningeal blood vessels that are thought to directly initiate migraine. Now, it has been increasingly recognized that abnormal neural function may be a greater cause in the development of the disease and also in triggering an episode. Migraine is now believed to be associated with an increased neuronal excitability and episodes of cortical spreading depression.
A migraine may include intense throbbing pain, nausea, and sensitivity to light (aura) and sound. The condition is relatively common in adults aged 25 through 55 and is more prevalent in women. Triptans have been used in medications for the treatment of migraine. Included are: Sumatriptan®, Rizatrptan®, Naratriptan®, Zolmitriptan®, Eletriptan®, Almotriptan®, Frovatriptan®, and Avitriptan®. While effective in treating the occurrence of migraine, they have not proven effective for preventive treatment and do not provide long term relief. They act by temporarily constricting the brain's blood vessels relieving swelling. The etiology of migraine is not yet fully understood although a body of scientific research shows that certain biochemical mechanisms are repeatedly found in the pathophysiology of migraine including migraine with and also without aura.
Homeopathic remedies have included preparations having magnesium, ginger, ginkgo-biloba, feverfew, and melatonin, to name only a few. The amino acid tryptophan, in tablet or capsule form, is a commonly accepted method for the administration of tryptophan, and remains an available and effective way to elevate the level of serotonin within the brain. Also known is the prophylactic use of tryptophan in treating stress. In the treatment of migraine, however, clinical evidence shows that it is usually only moderately effective. Tests indicate that the primary benefits of tryptophan lie in its routine, daily use as a preventive. It has been found to minimize migraine frequency and in some cases, also headache intensity and duration. Repeatedly however, tryptophan has been shown to be ineffective in aborting or significantly mitigating pain after the onset of a migraine episode.
Therefore, a medication is needed that can be taken orally, and which allows accelerated delivery of medication to the central nervous system so as to reduce or eliminate the pain associated with migraine. An effective remedy, described herein, has been found to be effective in treating migraine headache from onset to completion.